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Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis

NCT04455763 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-01-19

No results posted yet for this study

Summary

Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy with thumb splinting vs. splinting only.

Patients with radiologically and clinically confirmed Eaton-Glickel II osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo SVF injection and splinting vs. splinting only.

Baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months after enrollment. The primary end-point is 6 months and the primary outcome is pain visual analogue scale and patient-rated wrist evaluation (PRWE).

Conditions

  • Thumb Osteoarthritis

Interventions

PROCEDURE

SVF

Adipose-derived stromal vascular fraction

OTHER

Splint

Thumb brace (Actimove® Rhizo Forte)

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • Töölö Hospital

    lead OTHER

Principal Investigators

  • Samuli Aspinen, M.D., Ph.D. · HUS Töölö Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2022-09-30
Completion
2023-03-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04455763 on ClinicalTrials.gov